The purpose of this study is to assess the multiple rising dose safety/tolerability and pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and overweight/obese participants with Type 2 diabetes mellitus (T2DM).

A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Healthy Overweight/Obese Subjects and Patients With Type 2 Diabetes Mellitus

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Number of participants who experienced at least one adverse event [ Time Frame: Up to 49 days ] [ Designated as safety issue: Yes ]

Number of participants who discontinued from study drug due to an adverse event [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Area under the plasma concentration time curve from Hour 0 to Hour 24 (AUC0-24) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ] [ Designated as safety issue: No ]

Maximum plasma concentration (Cmax) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ] [ Designated as safety issue: No ]

Lowest plasma concentration (Ctrough) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ] [ Designated as safety issue: No ]

Time to maximum plasma concentration (Tmax) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ] [ Designated as safety issue: No ]

Apparent terminal half-life (apparent t1/2) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ] [ Designated as safety issue: No ]

MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level.

In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.

MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level.

In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.

MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level.

In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.

MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level.

In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.

MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level.

In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.

MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level.

In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.

For T2DM Panels, active treatment with any anti-hyperglycemic drug other than metformin

For T2DM Panels, treatment with any peroxisome proliferator-activated receptor-gamma agonist (e.g. Avandia or Actos) within 12 weeks of study participation

Unable to refrain from using any medication beginning 2 weeks before study participation

Consumes excessive amounts of alcohol (>3 per day)

Consumes more than 6 caffeinated beverages per day

Had major surgery or donated or lost more than 1 unit of blood

Participated in another investigational study within 4 weeks of study participation

History of significant multiple and/or severe allergies or anaphylactic reaction

Hypersensitivity to glucagon or insulin

Uses illicit drugs or has a history of drug or alcohol abuse within 3 months of study participation

Woman of child-bearing potential or is a nursing mother

For T2DM Panels, age >50 years

Contacts and Locations

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